4 Year Sepsis Study of New York’s Sepsis Regulations Being Launched By University of Pittsburgh Researcher

A University of Pittsburgh researcher is launching a four-year study of New York’s sepsis regulations to see what worked and what didn’t in the state’s fight against one of health care’s biggest killers.

Research has shown that speeding up sepsis treatment, which New York’s law accomplished, reduces deaths from the condition . The new study will examine the law more broadly, probing whether it might have had unintended negative consequences.

“Just because the protocol is good doesn’t mean that a regulatory-based effort to force hospitals to adopt these protocols led to better outcomes,” said Dr. Jeremy Kahn, a Pitt professor of critical care medicine and health policy and management who is heading the $1.5 million study.

New York required hospitals to adopt time-based sepsis protocols in 2013 after a 12-year-old boy, Rory Staunton, died from the condition after cutting his arm in a gym class a year earlier. The condition, in which the body’s immune system overreacts to infection, contributes to as many as half of all hospital deaths, according to the National Institutes of Health.

Sepsis has been likened to heart attacks and strokes, which killed many more patients before evidence-based treatment protocols were adopted. Hospitals in most states aren’t required to do anything specific to treat the condition, although many have voluntarily adopted protocols. Pennsylvania Health Department officials have said they plan to launch a two-year process this fall to incorporate sepsis protocols in the state’s hospital regulations.

New York’s protocols include taking blood cultures to guide diagnosis and treatment, analyzing lactate levels that can signify septic shock and administering fluids and antibiotics.

Kahn said the protocols raise concerns over two primary dangers: overuse of antibiotics and overuse of fluids.

The study of New York’s three-hour protocols found that administering fluids didn’t appear to improve outcomes, and too much fluid can lead to harm, Kahn said. Antibiotics, while a critical part of sepsis treatment, can also harm patients by killing good bacteria in the gut and creating a more welcoming environment for a deadly infection known as C-diff.

The new study, funded by the federal Agency for Healthcare Research and Quality, will examine complications, length of hospital stays, costs and other elements of the protocols, Kahn said. The study will compare sepsis treatment outcomes in New York to outcomes in Pennsylvania, Massachusetts, Washington and Florida, he said — states with similar numbers and types of hospitals.

“The hope would be to help policymakers in other states, specifically in Pennsylvania, as they design these regulations,” he said.

He expects bigger hospitals with more resources will have better sepsis outcomes than smaller rural hospitals. Another factor that might influence outcomes is whether hospitals have a designated sepsis specialist who influences how hospitals approach the condition.

Researchers plan to study the effects of sepsis policies for the first two years — delivering early results to Harrisburg before the planned update to hospital regulations — and to spend another two years interviewing doctors and health care specialists to gather more detail about how the protocols work.

“We can’t stand by as hundreds of thousands of Americans are dying each year of sepsis,” Kahn said. “But the question is, can we craft those policies; can the policy response to sepsis be evidence-based?”

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